| bCBT (n = 45) | CAU (n = 43) |  | ||||
---|---|---|---|---|---|---|---|
Mean | SE/SD* | Mean | SE/SD* | Mean difference | 95% CI | p value | |
Primary outcome | |||||||
 FCR (CWS) | |||||||
  T0 | 19.622 | 3.737 | 19.558 | 3.744 |  |  |  |
  T1 unadjusted | 14.814 | 4.579 | 18.487 | 3.986 |  |  |  |
  T1 adjusted | 14.743 | 0.432 | 18.277 | 0.454 | −3.534 | −4.764 to −2.305 | 0.000 |
  T2 unadjusted | 13.718 | 4.472 | 17.844 | 3.836 |  |  |  |
  T2 adjusted | 13.916 | 0.493 | 18.020 | 0.534 | −4.104 | −5.531 to − 2.677 | 0.000 |
  T3 unadjusted | 14.684 | 4.539 | 16.516 | 4.081 |  |  |  |
  T3 adjusted | 14.783 | 0.504 | 16.570 | 0.549 | −1.787 | −3.251 to −0.323 | 0.017 |
Secondary outcomes | |||||||
 Multidimensional aspects of FCR | |||||||
  Severity (FCRI) | |||||||
   T0 | 21.909 | 4.850 | 23.116 | 6.456 |  |  |  |
   T1 unadjusted | 16.605 | 7.251 | 22.282 | 5.991 |  |  |  |
   T1 adjusted | 16.989 | 0.756 | 21.330 | 0.788 | −4.341 | −6.497 to −2.185 | 0.000 |
   T2 unadjusted | 15.025 | 6.897 | 21.313 | 5.171 |  |  |  |
   T2 adjusted | 15.957 | 0.688 | 20.462 | 0.742 | −4.505 | −6.513 to −2.497 | 0.000 |
   T3 unadjusted | 15.842 | 7.343 | 19.733 | 5.539 |  |  |  |
   T3 adjusted | 16.599 | 0.805 | 19.023 | 0.879 | −2.423 | −4.785 to −0.062 | 0.044 |
Distress, depression, anxiety | |||||||
 Distress (HADS) | |||||||
  T0 | 14.089 | 7.836 | 15.209 | 8.911 |  |  |  |
  T1 unadjusted | 9.951 | 8.402 | 17.131 | 9.519 |  |  |  |
  T1 adjusted | 10.749 | 0.731 | 16.003 | 0.763 | −5.254 | −7.334 to −3.174 | 0.000 |
  T2 unadjusted | 9.718 | 7.412 | 15.862 | 9.771 |  |  |  |
  T2 adjusted | 11.139 | 0.806 | 14.897 | 0.898 | −3.759 | −6.134 to −1.383 | 0.002 |
  T3 unadjusted | 9.778 | 8.292 | 14.889 | 9.390 |  |  |  |
  T3 adjusted | 11.414 | 0.966 | 13.228 | 1.082 | −1.813 | −4.669 to 1.043 | 0.213 |
 Anxiety (HADS) | |||||||
  T0 | 8.156 | 4.101 | 8.395 | 4.914 |  |  |  |
  T1 unadjusted | 5.317 | 4.239 | 9.447 | 5.012 |  |  |  |
  T1 adjusted | 5.639 | 0.437 | 8.951 | 0.456 | −3.312 | −4.555 to −2.068 | 0.000 |
  T2 unadjusted | 5.333 | 4.132 | 8.862 | 5.585 |  |  |  |
  T2 adjusted | 6.030 | 0.528 | 8.549 | 0.588 | −2.519 | −4.074 to −0.964 | 0.002 |
  T3 unadjusted | 4.944 | 4.056 | 8.333 | 4.844 |  |  |  |
  T3 adjusted | 5.751 | 0.570 | 7.734 | 0.638 | −1.984 | −3.667 to − 0.301 | 0.021 |
 Depression (HADS) | |||||||
  T0 | 5.933 | 4.218 | 6.814 | 4.722 |  |  |  |
  T1 unadjusted | 4.634 | 4.598 | 7.684 | 5.152 |  |  |  |
  T1 adjusted | 5.050 | 0.424 | 7.131 | 0.442 | −2.081 | −3.286 to −0.876 | 0.001 |
  T2 unadjusted | 4.385 | 4.017 | 7.000 | 4.751 |  |  |  |
  T2 adjusted | 5.042 | 0.418 | 6.406 | 0.467 | −1.363 | −2.597 to −0.130 | 0.030 |
  T3 unadjusted | 4.833 | 4.675 | 6.556 | 4.956 |  |  |  |
  T3 adjusted | 5.582 | 0.504 | 5.611 | 0.565 | −.029 | −1.520 to 1.462 | 0.970 |
 Cancer-specific distress (IES) | |||||||
  T0 | 23.044 | 14.555 | 24.902 | 15.604 |  |  |  |
  T1 unadjusted | 14.732 | 14.998 | 26.026 | 17.747 |  |  |  |
  T1 adjusted | 15.539 | 2.064 | 24.598 | 2.208 | −9.059 | −15.003 to −3.115 | 0.003 |
  T2 unadjusted | 9.973 | 13.710 | 16.643 | 15.905 |  |  |  |
  T2 adjusted | 11.127 | 2.085 | 17.107 | 2.391 | −5.979 | −12.215 to 0.256 | 0.060 |
  T3 unadjusted | 14.944 | 14.633 | 18.259 | 15.294 |  |  |  |
  T3 adjusted | 15.781 | 2.147 | 17.254 | 2.450 | −1.473 | −7.883 to 4.938 | 0.653 |
 Fatigue (CIS-8R) | |||||||
  T0 | 30.222 | 12.951 | 36.116 | 12.585 |  |  |  |
  T1 unadjusted | 25.250 | 11.535 | 36.684 | 13.001 |  |  |  |
  T1 adjusted | 27.961 | 1.137 | 33.478 | 1.176 | −5.516 | −8.771 to −2.262 | 0.001 |
  T2 unadjusted | 26.769 | 11.855 | 32.586 | 12.290 |  |  |  |
  T2 adjusted | 28.694 | 1.297 | 30.512 | 1.444 | −1.818 | −5.658 to 2.022 | 0.353 |
  T3 unadjusted | 26.806 | 11.436 | 30.556 | 13.042 |  |  |  |
  T3 adjusted | 29.387 | 1.350 | 26.888 | 1.514 | 2.499 | −1.522 to 6.521 | 0.223 |
Quality of life (EORTC QLQ-C30) | |||||||
 Global quality of life | |||||||
  T0 | 62.222 | 19.672 | 61.434 | 20.252 |  |  |  |
  T1 unadjusted | 73.062 | 19.402 | 57.479 | 20.483 |  |  |  |
  T1 adjusted | 72.504 | 2.556 | 58.075 | 2.682 | 14.429 | 7.153 to 21.705 | 0.000 |
  T2 unadjusted | 72.083 | 21.229 | 62.500 | 21.792 |  |  |  |
  T2 adjusted | 71.918 | 3.004 | 62.632 | 3.264 | 9.286 | 0.576 to 17.997 | 0.037 |
  T3 unadjusted | 73.026 | 19.609 | 65.278 | 19.948 |  |  |  |
  T3 adjusted | 72.672 | 2.823 | 67.742 | 3.108 | 4.930 | −3.331 to 13.192 | 0.242 |
 Physical functioning | |||||||
  T0 | 87.704 | 13.406 | 83.953 | 16.269 |  |  |  |
  T1 unadjusted | 89.380 | 11.735 | 80.855 | 20.010 |  |  |  |
  T1 adjusted | 87.552 | 1.527 | 82.886 | 1.606 | 4.666 | .296 to 9.037 | 0.036 |
  T2 unadjusted | 88.750 | 15.148 | 86.458 | 14.809 |  |  |  |
  T2 adjusted | 86.246 | 1.737 | 87.766 | 1.893 | −1.519 | −6.583 to 3.545 | 0.557 |
  T3 unadjusted | 89.649 | 13.924 | 84.301 | 14.560 |  |  |  |
  T3 adjusted | 87.986 | 1.592 | 86.829 | 1.721 | 1.156 | −3.479 to 5.792 | 0.625 |
 Role functioning | |||||||
  T0 | 77.037 | 26.181 | 74.806 | 25.295 |  |  |  |
  T1 unadjusted | 85.659 | 21.076 | 74.123 | 23.474 |  |  |  |
  T1 adjusted | 84.543 | 2.963 | 75.547 | 3.142 | 8.996 | 0.503 to 17.489 | 0.038 |
  T2 unadjusted | 83.750 | 23.415 | 82.292 | 21.972 |  |  |  |
  T2 adjusted | 82.766 | 3.407 | 82.705 | 3.742 | 0.061 | −9.887 to 10.008 | 0.991 |
  T3 unadjusted | 89.035 | 17.013 | 84.409 | 23.148 |  |  |  |
  T3 adjusted | 87.388 | 2.777 | 85.357 | 3.043 | 2.031 | −6.095 to 10.157 | 0.624 |
 Emotional functioning | |||||||
  T0 | 64.815 | 22.883 | 66.860 | 22.456 |  |  |  |
  T1 unadjusted | 81.589 | 23.185 | 60.256 | 29.830 |  |  |  |
  T1 adjusted | 81.647 | 2.934 | 59.978 | 3.078 | 21.669 | 13.326 to 30.011 | 0.000 |
  T2 unadjusted | 80.208 | 22.463 | 61.719 | 28.544 |  |  |  |
  T2 adjusted | 78.959 | 3.259 | 60.785 | 3.540 | 18.174 | 8.731 to 27.617 | 0.000 |
  T3 unadjusted | 77.851 | 23.592 | 68.548 | 25.973 |  |  |  |
  T3 adjusted | 77.507 | 2.987 | 68.668 | 3.242 | 8.839 | 0.179 to 17.499 | 0.046 |
 Cognitive functioning | |||||||
  T0 | 72.963 | 24.692 | 68.992 | 25.350 |  |  |  |
  T1 unadjusted | 80.620 | 19.897 | 62.393 | 28.541 |  |  |  |
  T1 adjusted | 79.977 | 2.920 | 64.662 | 3.071 | 15.315 | 6.989 to 23.641 | 0.000 |
  T2 unadjusted | 82.500 | 19.954 | 72.917 | 28.945 |  |  |  |
  T2 adjusted | 80.130 | 3.276 | 74.990 | 3.593 | 5.140 | −4.421 to 14.701 | 0.292 |
  T3 unadjusted | 79.386 | 22.738 | 68.280 | 25.587 |  |  |  |
  T3 adjusted | 76.994 | 3.171 | 71.780 | 3.442 | 5.214 | −4.013 to 14.441 | 0.268 |
 Social functioning | |||||||
  T0 | 80.000 | 23.192 | 71.318 | 24.754 |  |  |  |
  T1 unadjusted | 89.922 | 17.495 | 76.923 | 26.384 |  |  |  |
  T1 adjusted | 87.868 | 2.907 | 79.225 | 3.055 | 8.643 | 0.306 to 16.979 | 0.042 |
  T2 unadjusted | 85.833 | 22.504 | 80.208 | 22.175 |  |  |  |
  T2 adjusted | 83.302 | 3.052 | 81.127 | 3.310 | 2.176 | −6.727 to 11.078 | 0.632 |
  T3 unadjusted | 88.158 | 19.723 | 86.022 | 19.292 |  |  |  |
  T3 adjusted | 85.924 | 2.556 | 89.059 | 2.759 | 3.135 | −10.641 to 4.370 | 0.413 |